Stephen Oakes

Mrs M Jones 
Assistant Coroner 
HM Coroner’s Office 
547 Hartshill Road 
Stoke-on-Trent 
ST4 6HF 

19 July 2021 

Dear Mrs Jones 

Medicines & Healthcare products 
Regulatory Agency 

10 South Colonnade  
Canary Wharf  
London  
E14 4PU 
United Kingdom 

gov.uk/mhra 

Regulation 28 request relating to the death of Mr Stephen Oakes 

, Nasogastric tubes 

I  write  with  reference  to  your  Regulation  28  report  (dated  19  April  2021)  concerning  the  death  of  Mr 
Stephen  Oakes.  Mr  Oakes  suffered  post-surgical  complications,  which  included  the  use  of  a  Carefeed 
14Fr  nasogastric tube that  inadequately  drained his  stomach  contents,  allowing  vomiting past  the  tube 
leading to aspiration pneumonia, against a background of significant natural disease.  

Your  report  was  received  by  MHRA  on  the  10  June  2021  via  NHS  England  and  Improvement.  Both 
organisations agreed to provide a separate response to address concerns relevant to each organisation, 
as 
(Supply  Chain 
Stakeholders/MHRA/NHS Supply Chain/British Standards and Industry Groups) to which it was addressed 
has been disbanded. 

the  NHS  England  Small  Bore  Connector  Clinical  Advisory  group 

We have previously provided a report to the Coroner on 5 March 2021 to assist with the inquest. Following 
the inquest you raised the matters of concern below:  

(1)  The  product  description  used  by  Enteral  was  insufficient  to  enable  the  end  user  to  clearly 
identify  that  the  tube  marketed  as  a  Carefeed  size  14Fr  feeding  and  drainage  tube  would  not 
operate as a 14Fr tube due to the restricting en-fit connector.   
(2) Enteral sales marketing staff were not trained to recognise the new restriction in the bore of the 
tube and were consequently unable to advise the end user of the change.  
(3) The Hospital Trust did not fully evaluate the size 14Fr tube prior to replacing all previous drainage tubes 
(Ryles) with the Carefeed 14Fr feeding and drainage tube. Feedback was generally difficult to obtain.   
(4)  Nursing  staff  did  not  consider  alternative  action  when  the  nasogastric  tubes  were  not  adequately 
draining. There was no general recognition of the need to aspirate the tube.   
(5) There is no compulsory training of clinicians required to undertake root cause analysis.  
(6) Despite reports to the MHRA and issue of amended instructions for use and a field safety notice 
the product continues to be promoted as suitable to feeding and drainage.   
(7) This was a joint inquest into the deaths of two patients who died in quick succession as a result 
of the  Enteral  14Ff  nasogastric  tubes  being  used for  decompression in an  emergency  situation. 
Four  similar  (non-fatal)  incidents  followed.  It  was  not  clear  to  the  hospital  that  the  Enteral 
connector reduced the bore of the size 14Fr tube. The inquest was aware that other Hospital Trusts 
had also needed to change the tubes. I am concerned that the product labelling problem identified 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 during these inquests may not be limited to the University Hospital North Midlands but is in fact a 
much wider problem that merits wider industry investigation and changes.  

We  would  like  to  address  the  highlighted  concerns  1,  2,  6  and  7  relevant  to  our  regulatory  role.  The 
manufacturer,  GBUK,  has  informed  us  that  they  have  updated  the  product  labelling for  the  Carefeed 
devices to remove the secondary intended use of drainage. The primary intended use is clearly stated as 
’Feeding Tube’. We understand GBUK has recently communicated this to you. We continue to engage 
with GBUK on the outstanding issue regarding update to their website for the instructions for Use (IFU) on 
Carefeed devices. They are currently reviewing their website and aim to complete this action within the 
next 2 months. The above addresses concern 1. 

In relation to concerns 2, 6 and 7, we will continue to collaborate with NHS England and Improvement on 
the best way to address this issue, such as raising awareness on the Medical Devices Safety  Officers’ 
(MDSO)  network.  We  will  write  to  UK  manufacturers  of  nasogastric  tubes  to  advise  them  of  the  risk 
associated with the use of the ISO standard ENFit connector in aspiration/decompression situations and 
ask them to update their risk assessment if not already done. We will advise that where applicable, they 
should conduct a Field Safety Corrective Action (FSCA) and update their IFU, ensuring that their staff are 
fully trained in the changes so that they can provide advice to clinicians where necessary. This action will 
be completed within 1 month.  

In addition, we have contacted the British Association for Parenteral and Enteral Nutrition (BAPEN) and 
the National Nurses Nutrition Group (NNNG) to raise further awareness of this issue.  

We have not received any similar reports to date.  

We  understand  from  NHS  England  and  Improvement  that  a  separate  response  has  been  provided  to 
yourself covering points 3, 4 and 5.   

I hope this information is reassuring to you.  

Thank you for bringing this important patient safety issue (Regulation 28 report) to our attention and please 
contact me should you need any further information.  

Yours sincerely, 

Director of Devices 
MHRA

Margaret Jones,  HM Assistant  Coroner 
HM Coroner's  Court & Chambers 
Stoke Town Hall 
Kingsway 
Stoke-on-Trent 
ST4 1HH 

National  Medical  Director 
NHS England  & NHS Improvement 
Skipton House 
80  London  Road 
London 
SE1  6LH 

29th June 2021 

Dear Ms Jones, 

Re:  Regulation  28 Report to Prevent Future Deaths - Stephen  James  Oakes 

Thank you for your Regulation  28 Report (hereafter 'report')  dated  19 April  2021 
concerning  the death of Mr Stephen  James Oakes on 23 December 2017.  Firstly,  I 
would  like to express my deep condolences  to Mr Oakes's family. 

The report concludes  Mr Oakes's death was a result  of "complications  caused  by the 
use of a  carefeed 14F nasogastric  tube which  inadequately  drained  stomach 
contents allowing  vomiting  passed  (sic) the tube  leading  to aspiration  pneumonia  on 
a background  of significant  natural  disease  and  death". 

Following  the  inquest you raised  concerns in  your report to NHS England  and NHS 
Improvement (NHSE/I) as follows: 

1.  The product description  used  by Enteral was insufficient to enable  the end user  to 

clearly  identify that the tube marketed as a  carefeed size  14FR feeding  and 
drainage  tube would  not operate as a  14Fr tube due to  the restricting  en-fit 
connector. 

2.  Enteral  sales  marketing  staff were not trained  to recognise  the new restriction  in 
the bore of the tube and were consequently  unable  to  advise the end  user of the 
change. 

3.  The Hospital  Trust did  not fully evaluate the size 14FR tube  prior to replacing  all 
previous  drainage tubes  (Ryles) with the Carefeed  14Fr feeding  and  drainage 
tube.  Feedback was generally  difficult to obtain. 

4.  Nursing  staff did  not consider alternative  action when the nasogastric  tubes  were 
not adequately  draining.  There  was no general  recognition  of the need to aspirate 
the tube. 

NHS England and NHS Improvement 

Cl:) 

 
 
 5.  There is  no compulsory training  of clinicians  required  to undertake  root cause 

analysis. 

6.  Despite  reports to the  MHRA and  issue  of amended  instructions  for use  and  a 

field  safety notice the  product continues  to be promoted  as suitable  to feeding  and 
drainage. 

7.  This was a joint  inquest  into the deaths  of two patients  who died  in quick 

succession  as a result  of the  Enteral  14F nasogastric  tubes  being  used  for 
decompression  in  an  emergency situation.  Four similar  (non-fatal) incidents 
followed.  It was not clear to the hospital  that the Enteral  connector reduced the 
bore of the size  14Fr tube.  The inquest  was aware that other Hospital  Trusts had 
also  needed  to  change the tubes.  The  product labelling  problem  identified  during 
these  inquests  may not be  limited  to the  University Hospital  North Midlands  but is 
in fact a much wider problem  that merits wider industry  investigation  and  changes. 

Further to the email sent on  10 June 2021  from 
my Quality  Strategy Team,  I am conscious that the majority of your concerns would 
be  better placed  with the Local Trust,  to whom you have sent  the report,  and 
colleagues  at the  Medicines and  Healthcare  products  Regulatory  Agency (MHRA). 
The Small Bore Connector Group,  which you  refer to in the addressees  of the report 
was discontinued  some time ago.  On that basis  I have shared  the report with 
colleagues  at MHRAwho I understand  will  address  the concerns relevant to their 
area of work. 

, Business  Manager  in 

In  terms of wider patient safety,  NHSE/l's Patient Safety Team  have discussed  this 
issue  and  are currently  undertaking  a review of the National  Reporting  and  Learning 
System (NRLS) to see if they  can identify any reported  incidents  since  January 2018; 
when  GBUK issued  a Field  Safety Notice in  respect of this issue.  Pending  the 
outcome of this  review,  Patient Safety colleagues  will work with  MHRA to determine 
if any further action is required. 

In relation  to concern 5,  around  Root Cause Analysis training,  it is important to  note 
that all  NHS trusts  are required  to comply with the  Serious  Incident  Framework 
(2015) when conducting patient  safety incident  investigations  into incidents  such as 
the tragic events described.  The Framework states that; 

"The  investigation  must be conducted  using  a recognised  systems-based 

investigation  methodology  that identifies: 

•  The problems (the  what?); 
•  The contributory  factors that led to the  problems  (the how?),  taking into 

account the environmental  and  hum an factors;  and 

•  The fundamental  issues/root  cause  (the why?) that need  to be addressed. 

Within  the  NHS, the recognised  approach  is commonly termed  Root Cause Analysis 
(RCA) investigation.  The investigation  must be undertaken  by those  with appropriate 
skills,  training  and  capacity."  (p23,  Serious  Incident  Framework) 

 It further states  that investigation  team  members must have "knowledge  of what 
constitutes  an  effective systems investigation  process,  and  the  skills/ competencies 
to lead and  deliver  this"  (p37). 

Recognising  that there are well identified  and  publicised  issues  with the quality of 
patient safety investigations  in the NHS, there  is ongoing  work, as part of the NHS 
Patient  Safety Strategy, to pilot a new framework for incident response:  the  Patient 
Safety Incident Response  Framework (PSIRF).  This framework focusses on the 
importance of conducting  a system-based  patient safety incident investigation.  Much 
like the  Serious  Incident Framework, the  PSIRF, and  the  Patient Safety Incident 
Investigation  Standards  which sit  alongside  it,  require  investigators  to  be 
appropriately  trained. 

NHS England  and NHS Improvement are working with the  Healthcare  Safety 
Investigation  Branch (HSIB); who are testing  and  introducing  national  patient  safety 
incident investigation  training.  In addition,  a patient  safety incident investigation 
training  procurement  framework is also  being developed  to support  healthcare 
providers  and  commissioners to access quality  assured  investigation  training. 

Thank  you for bringing this  important  patient  safety issue  to my attention  and  please 
do not hesitate  to contact me should  you need any further information. 

Yours sincerely, 

Professor 
National  Medical Director

Enteral Feeding Devices 

GBUK Enteral Ltd. 
Woodland Hou, e  Bla ckwood Hall Bus m  s,  Park 
North Duffield  Selby  N  rth York, h r~  Y08 500 

Margaret Jones 
HM Assistant Coroner 
Stoke-on-Trent & North Staffs Coroners Court 

17 June 2021 

Dear Madam, 

W  www.gbukenterol c;om 
E  onfo1:t-gbukenterol corn 

D  .aGBUK_Group 
D  .dGBUKEnteral 
11:1  GBUKGroup 
a  GBUKGroup

I write regarding concerns raised in your Regulation 28 report to prevent future deaths, 
relating to the conjoined inquest of Mr Peter Hussey and Mr Stephen Oakes and the steps 
taken by GBUK Enteral Ltd to address them. 

Firstly, addressing concerns raised relating to the device description and the restriction 
posed by the EN Fit connector when used for drainage on some larger Fr size tubes. We 
have now revised our device labelling and the Instructions For Use (IFU), with all 
references to drainage now completely removed from our device labelling descriptions. 

Within the revised IFU the following additional warnings &  precautions are now present: 
• Routinely check flow and tube impairment.  If the tube is used for drainage, failure to clear 
the obstruction may cause gas & fluid build-up in stomach, aspiration of gastric contents, 
aspiration pneumonia and other complications. 
• The device should not be used for high volume decompression in emergency situations, 
and/or decompression of highly viscous fluids other than gastric secretions. 
• From sizes 14Fr and above, the internal diameter of the industry standard ENFit ISO 
80369-3 connector is smaller than the internal diameter of the tube. Flow rate will be 
limited by the  EN Fit connector for these sizes. 

The term drainage has been removed from the "Intended Use" section of the IFU and 
packaging labels. In the revised  IFU we clearly identify to the user that the intended use of 
the product is a feeding tube. The additional warnings & precautions in the revised  IFU 
further explain very clearly the limitations of the tube if the user opts to use the tube for the 
dual purposes of feeding and drainage. This will be implemented as new stock of these 
devices are manufactured. 

We have also contacted NHS supply chain to request the device description be changed 
on their website from "Gastrostomy tubes for general use" to "Nasogastric Feeding Tube", 
which we hope will be implemented soon. 

Regarding concerns that our Enteral sales staff were not trained to recognise the 
restriction posed by the ENFit connector, in order to advise end users.  I reiterate the point 
made in my previous correspondence to you ( 19th  April 2021 ), that all members of the 
Enteral sales team fully understand that our Nasogastric Feeding tubes are not a 
replacement for a Ryles tube, with its primary purpose being that of feeding and its 
secondary purpose being limited forms of drainage. 

We have also ensured that up to date refresher training has been provided to our sales 
force. This training was given on the 21st April 2021, covering in detail the intended use of 

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 Nasogastric feeding tubes and also specifically EN Fit connectors and the impact on the 
tubes flow rate. A copy of the training presentation has been provided, which you will see 
contains the key topics of concerns. Staff attending were also tested at the end of the 
training provided, to ensure all key points had been understood. Any new sales staff will 
also receive this training and refresher training is provided to our sales force at regular 
intervals. 

I hope this addresses the concerns raised within your report and should you have any 
queries regarding this letter or require any further clarification please do not hesitate to 
contact us and we will be more than happy to assist. 

Yours faithfully 

Technical Director 
For and on behalf of GBUK Group Ltd 

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University Hospitals 
of North Midlands 
NHS Trust 

Royal Stoke University Hospital 
Executive Suite 
Springfield 
Newcastle Road 
Stoke-on-Trent 
Staffordshire 
ST4 6QG 

23 June 2021 

Mrs M Jones 
H M Assistant Coroner 
547 Hartshill Road 
Stoke on Trent 
ST4 6HF 

Dear Mrs Jones 

Co-joined Inquests touching the deaths of Peter Hussey and Stephen Oakes 

Further to your letters dated 19 April 2021, I am pleased to provide the following  response to address the 
concerns  that  you  raised  at  the  co-joined  inquests  touching  the  deaths  of Stephen  Oakes  and  Peter 
Hussey. 

You raised a  number of matters of concern to be addressed by several organisations and we have taken 
the  opportunity  to  address  matters  directly  relating  to  the  University  Hospitals  of North  Midlands  NHS 
Trust, which were highlighted by you as follows: 

1.  The Hospital Trust did not fully evaluate the size 14FR tube prior to replacing all previous drainage 
tubes (Ryles) with the carefeed 14Fr feeding and drainage tube. Feedback was generally difficult 
to obtain. 

2.  Nursing staff did not consider alternative action when the NG tubes were not adequately draining. 

There was no general recognition of the need to aspirate the tube. 

3.  There is no compulsory training of clinicians required to undertake root cause analysis. 

Action Taken 
During  the  course  of  the  inquest,  you  were  appraised  of  improvements  that  had  already  taken  place 
across the Trust,  however, in addition we are pleased to advise of the following significant improvements. 

1.  The  Hospital Trust did not fully evaluate the size  14Fr tube prior to replacing all previous drainage 
tubes  (Ryles)  with  Carefeed 14Fr feeding  and drainage tube.  Feedback was  generally difficult to 
obtain 

Matters  relating  to  the  inquest  touching  upon  the  deaths  of  Mr  Hussey  and  Mr  Oakes  were 
discussed  at the  Medical  Device  Strategy  Committee  (MDSC)  and  as  a  consequence,  a  new 
proforma  for evaluating  equipment has  been designed  and  will  be  used  to  collect feedback from 
users  during  the  initial  trial  period.  As  indicated at  the  inquest,  the  recently appointed  Specialist 
Nurse will  assist in gathering this data. 

Page 1 of 1 

 
 
 
 We are also looking  at trialling  new equipment  (where  appropriate)  in  the Trust Extended  Reality 
Laboratory (ERL);  this is a simulation facility and will  assist  in identifying  any gross issues before 
implementing trial periods in the clinical areas. 

2.  Nursing staff did not consider alternative action when  the NG tubes were not adequately draining. 

There was no general recognition of the need to aspirate the tube. 

The  Trust  Nasogastric  Working  Group,  chaired  by  the  Lead  Nurse for Quality and  Safety,  have 
overseen  a  focused  piece  of work  to  review and  update  the  Local Safety Standards for Invasive 
Insertion  of Nasogastric I  Orogastric  Tubes,  to  include  'troubleshooting' 
Procedure  (LocSSIP}  -
guidance  regarding  aspiration  of  Nasogastric/Orogastric  tubes  inserted  for  the  purpose  of 
drainage.  Troubleshooting  guidance  will  also  be  provided  in  both  nursing  and  medical  clinical 
guidelines. 

training  package 

The  Trust  e-learn ing 
insertion  and  on-going  management  of 
Nasogastris/Orogastric  tubes  has  also  been  updated  to  include  'troubleshooting'  guidance  on 
aspiration  of Nasogastric/Orogastric  tubes  and  includes  the  development  of a  competency  and 
self-assessment  document;  this  will  ensure  that  all  registrants  involved  in  the  management  of 
Nasogastric/Orogastric tubes are competent to do so. 

the 

for 

3.  There  is no compulsory training of clinicians required to undertake root cause analysis. 

The Trust continue  to  provide  RCA  training  for clinicians across  the  organisation. Whilst  training 
was  available prior  to  the  inquest  touching  the  deaths  of Mr Hussey  and  Mr Oakes,  we  aim  to 
increase  the  number  of  staff  who  are  trained  in  the  basic  principles  and  tools  for  RCA 
investigations. All  names of staff who  have  undergone  RCA training  will  be  entered  onto  a  staff 
database and future Investigating  Officers will be selected from this list. 

I  have  also enclosed  a  copy of  the  action  plan  that has been  developed following  the  inquest  and  I  do 
hope that it demonstrates our intention to improve the services provided at the Trust. 

I sincerely  hope that the  above  information  provides you with  assurance that the University  Hospitals  of 
North Midlands NHS Trust has taken  the matters arising from  the inquest touching  upon the deaths of Mr 
Hussey and Mr Oakes  seriously. The Trust strives to provide a high  standard of care to all patients and I 
am grateful to you for raising these concerns on this occasion. 

Should you wish to discuss any aspect of this report further,  please do not hesitate to contact me. 

Yours sincerely 

CHIEF EXECUTIVE 

Enclosure: Action Plan 

Page 2 of 1